Duns Number:333623937
Device Description: PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALA PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALAMIX® uno or PALAMIX® duo vacuum mixing systemPALAMIX® uno and PALAMIX® duo allow for automatic collection of bone cement within the mixing cartridge under vacuum.
Catalog Number
66057897
Brand Name
PALAMIX®
Version/Model Number
DUO
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JDZ
Product Code Name
Mixer, Cement, For Clinical Use
Public Device Record Key
7ccae487-d9bc-4d42-a691-d2bb176299ba
Public Version Date
May 13, 2019
Public Version Number
4
DI Record Publish Date
March 16, 2018
Package DI Number
04260102133631
Quantity per Package
160
Contains DI Package
04260102133617
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |